Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.


Patrocinador principal: XOMA (US) LLC

Fuente XOMA (US) LLC
Resumen breve

The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.

Estado general Completed
Fecha de inicio April 2002
Fecha de Terminación August 2003
Fase Phase 2
Tipo de estudio Interventional

Tipo de intervención: Drug

Nombre de intervención: efalizumab



Inclusion criteria:

- Clinical diagnosis of moderate to severe rheumatoid arthritis.

- On stable dose of methotrexate.

- 18 to 80 years of age.

- Less than 275 lbs.

Exclusion criteria:

- Joint replacement surgery within 60 days of the start of drug dosing.

- Intra-articular cortisone injections within 28 days of the start of drug dosing.

- Pregnancy.

- History of severe allergic or anaphylactic reactions.

- Active bacterial, viral, fungal, mycobacterium tuberculosis.

- Positive PPD test.

- History of any opportunistic infection.

- Serious persisting local or systemic infection.

- History of malignancy within the past five years.

- Received any vaccine within 28 days of the start of study drug dosing.

- Joint replacement therapy planned within nine months of the start of study drug dosing.

- Chronic disorders apart from RA affecting the joints.

- Significant systemic involvement secondary to RA.

- COPD, asthma, or other pulmonary disease.

- Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing.

- Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing.

- Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing.

- Liver disease or abnormal hepatic function.

- Serum creatinine level > 1.5 mg/dL.

- Platelet count < 125,000 cells/mm3.

- WBC count < 3,500 cells/mm3.

- Seropositive for hepatitis B surface antigen.

- Seropositive for hepatitis C antibody.

- Known seropositivity for HIV.

Género: All

Edad mínima: 18 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

University of Alabama at Birmingham | Birmingham, Alabama, 35294, United States
Rheumatology Associates of North Alabama | Huntsville, Alabama, 35801, United States
Arizona Arthritis Research, PLC | Paradise Valley, Arizona, 85253, United States
Advanced Clinical Therapeutics, LLC | Tucson, Arizona, 85715, United States
NEA Clinic | Jonesboro, Arkansas, 72401, United States
Little Rock Diagnostic Clinic | Little Rock, Arkansas, 72205, United States
University of California at San Diego | La Jolla, California, 92093-0943, United States
UCLA | Los Angeles, California, 90024, United States
Wallace Rheumatic Study Center | Los Angeles, California, 90048, United States
Boling Clinical Trials | Rancho Cucamonga, California, 91730, United States
Desert Medical Advances | Rancho Mirage, California, 92270, United States
The San Diego Arthritis and Osteoporosis Medical Clinic | San Diego, California, 92120, United States
Pacific Arthritis Center | Santa Maria, California, 93454, United States
Northeast Clinical Research, LLC | Hamden, Connecticut, 06518, United States
Clinical Research Consultants, Inc. | Trumbull, Connecticut, 06611, United States
Clinical Research of West Florida | Clearwater, Florida, 33765, United States
The Center for Rheumatology, Immunology and Arthritis | Ft. Lauderdale, Florida, 33334, United States
Anchor Research Center | Naples, Florida, 34102, United States
Rheumatology Associates of Central Florida | Orlando, Florida, 32806, United States
nTouch Research Corporation | St. Petersburg, Florida, 33710, United States
Tampa Medical Group | Tampa, Florida, 33614, United States
nTouch Research Corporation | Vero Beach, Florida, 32962, United States
Palm Beach Research Center | West Palm Beach, Florida, 33409, United States
nTouch Research Corporation | Decatur, Georgia, 30033, United States
nTouch Research Corporation | Marietta, Georgia, 30066, United States
Tri-State Arthritis and Rheumatology Center, LLC | Evansville, Indiana, 47714, United States
Central Iowa Hospital Corporation | Des Moines, Iowa, 50309, United States
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States
Phase III Clinical Research | Fall River, Massachusetts, 02720, United States
The Center for Pharmaceutical Research | Kansas City, Missouri, 64114, United States
Washington University Center for Clinical Studies | St. Louis, Missouri, 63110, United States
Clinical Research Center of Nevada | Las Vegas, Nevada, 89128, United States
Albert Einstein College of Medicine | Bronx, New York, 10461, United States
State University of New York Health Science Center at Brooklyn | Brooklyn, New York, United States
Bassett Healthcare Clinical Pharmacology Research Center | Cooperstown, New York, 13326, United States
Long Island Jewish Medical Center | New Hyde Park, New York, 11040, United States
Hospital for Joint Disease, ACRC | New York, New York, 10003, United States
Mount Sinai School of Medicine | New York, New York, 10029, United States
Prem C. Chatpar, M.D. | Plainview, New York, 11803, United States
State University of New York Upstate Medical University | Syracuse, New York, 13210, United States
McBride Clinic, Inc. | Oklahoma City, Oklahoma, 73103, United States
Altoona Center for Clinical Research | Duncansville, Pennsylvania, 16635, United States
nTouch Research Corporation | Pittsburgh, Pennsylvania, 15218, United States
Rheumatic Disease Associates | Willow Grove, Pennsylvania, 19090, United States
Volunteer Research Group, LLC | Knoxville, Tennessee, 37920, United States
Summit Research Solutions, Inc. | Memphis, Tennessee, 38119, United States
Vanderbilt University | Nashville, Tennessee, 37232-2681, United States
Amarillo Center for Clinical Research, Ltd. | Amarillo, Texas, 79106, United States
Austin Rheumatology Research | Austin, Texas, 78705, United States
Physicians' Research Options, LLC | Ogden, Utah, 84403, United States
South Puget Sound Clinical Research | Olympia, Washington, 98502, United States
University of Wisconsin, Madison | Madison, Wisconsin, 53792, United States
Ubicacion Paises

United States

Fecha de verificación

September 2004

Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Propósito primario: Treatment

Enmascaramiento: Double